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On its 25th anniversary, ARPIM launched a working paper with policy makers on health system resilience

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On the occasion of 25 years of activity in Romania and involvement in projects that have contributed to increasing access to medicines and quality of life for Romanian patients, the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) has launched a document for collaboration with policy makers, structured on 4 major axes:

The Health Innovation Pact was launched in an online event that brought together voices from political, government and administration, as well as patient representatives, together with manufacturers of innovative medicines.

Watch LIVE the PACT for Health event:


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“This is the right time to put Health at the forefront and unite all of us – policy makers, political parties, patient associations, experts, doctors and industry – around this Health Innovation Pact to rapidly improve the health system and meet the expectations of Romanian patients. The new Government has a unique opportunity to analyse, take up and prioritise the measures already identified in the collaborative document we are proposing. Thus, the innovative pharmaceutical industry, which demonstrated unprecedented mobilization during the COVID-19 pandemic, is positioned as a partner in increasing Romanian patients’ access to innovative medicines and therapeutic solutions”, said Alina Culcea, President of ARPIM.


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”Partnerships with the pharmaceutical industry are extremely important for access to innovative molecules. Access is only possible with such partnerships. In Romania, we can also find convenient solutions that make it possible for patients to access innovative molecules. We can discuss this quietly once we get through this crisis and I believe we can make it happen,” said the Minister-designate for Health.” – Alexandru Rafila, Minister of Health.

Read also: Health Innovation Pact | Future Health Minister Alexandru Rafila: Romania can be a partner for the innovative pharmaceutical industry. We will achieve this objective


“The last 2 years have been quite hard, years in which we have seen the need for collaboration, even if sometimes less accessible, of the authorities with the pharmaceutical industry, with central authorities, with local authorities, in the context that we still want to make an important step in everything that means health.

I have been talking about the need for health reforms since the year I was a minister. I believe that more in-depth discussions and legislation that responds to current needs are the solutions that we must find together at this time. The “new” in Romanian health, perceived by our other neighbours as a state of normality, should overcome some barriers. The barriers that you and I have encountered are on two levels: the level of those who approve or are studying these medicines and the level of legislation that must allow these medicines to enter the Romanian market as quickly as possible” – Nelu Tătaru, Chairman of the Health and Family Affairs Committee of the Chamber of Deputies.


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“We need to identify a partnership that has the right impact, a partnership that defines the missing cog that is most appropriate to prioritise at this time. We want to create all the conditions to standardise access and standards of health services at European level. The current context is forcing us to modernise and align legislation with European standards.

If we do not have practices and legislation aligned with the practices of other Member States, it is clear that Romania cannot keep up with the access to medicines that other countries offer their patients. By aligning with European standards, Romania becomes attractive to the whole manufacturing industry, which will bring real benefits to patients. Such a pact and initiative can solve important barriers and problems. ” – Andrei Baciu, State Secretary in Ministry of Health

Read also: Health Innovation Pact | Andrei Baciu: By aligning with European standards, Romania becomes attractive to the European manufacturing pharmaceutical industry


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“Adequate and effective funding for health care and better health policies lead to better health outcomes, but they also lead to improved economic and fiscal indicators. I would like to stress that medicine should not be seen as a box isolated from the rest of the health system. Innovative medicines bring value throughout the health system. From reducing side effects, to reducing hospital days and the need for medical procedures in hospital,” said Dr Ioana Bianchi.

Read also: Health Innovation Pact | Dr Ioana Bianchi, ARPIM External Relations Director: Innovative medicines bring value across the health system chain


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“The health crisis caused by the pandemic and the measures taken by the European Commission to support Member States and to improve coordination at EU level have put us firmly on the path towards a Health Union. Innovative therapies are not reaching European patients with the same speed, and some may not have access at all due to shortages. In addition, health systems and patients are finding it difficult to bear the costs of medicines” – Ramona Chiriac, Head of the European Commission Representation in Romania

Read also: Health Innovation Pact | Ramona Chiriac, Head of EC Representation in Romania: Innovative therapies are not reaching European patients with the same speed. Pharma industry part of the solution


“I unquestionably believe that innovation underpins the evolution of medical science and practice. Let’s face it, medical research has transformed our lives in the most profound ways and continues to do so at an ever-increasing pace. The evolving dynamics of new personalised therapies, new methods of diagnosis and intervention in complex cases, even with the support of artificial intelligence, telemonitoring, teleconsultation I think are enlightening examples, even the development and so rapid development of effective vaccines against SARS-CoV-2 is further proof. The healthcare system is under more pressure to innovate than ever before. I believe that with the right political support (…) we can ensure the sustainability of the new paradigm of care. For this we need a health innovation pact that allows us to address the multiple challenges of capitalising on innovative concepts and that can really support the transfer of innovation into clinical practice” – Diana-Loreta Păun, Presidential Adviser


 

“At the moment, the Romanian patient does not have access to about 40% of the innovative products that are currently used in Western Europe, there are many reasons for this, but if we look at the other aspects, including our legislation, I think we have a lot to do” – Laszlo Attila, Secretary Senate Health Committee


 

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”The major concern of the Romanian citizen is related to health: “64.3% of the Romanian respondents to the Public Health Barometer believe that health is the most acute problem they face today. Thus, if there is something to be done to satisfy the majority of the population and to have the highest level of public visibility, it must be done at health level. The most effective, including politically, is to start with health. The population at the 65% level is looking at health. This is the sociological reality”, said Prof. Univ. Dr. Dan Dungaciu

Read also: Health Innovation Pact | Prof. Univ. Dr. Dan Dungaciu: Romanians want a country like abroad in healthcare


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“Innovation saves lives. There are many patients with autoimmune diseases who 15 years ago had no treatment options at all, or only had access to treatments with many side effects, and now they are benefiting from all these innovative therapies that have practically changed their lives, made them forget they have a chronic disease and can now do what they never dreamed of years ago. It is clear that we need access to innovation, it is clear that we need more education on the innovation side. That’s what we do as a patient association, we try to bring as much information as possible to people. The pandemic has kick-started a medical education system and that is a good part of the pandemic, because it has forced an openness to medical topics. I hope that mechanisms will be found to increase access to innovative therapies”, said Rozalina Lăpădatu, President of the Association of Patients with Autoimmune Diseases

Read also: Health Innovation Pact | Rozalina Lăpădatu, President of APPA: Patient associations bring medical education closer to the people


ARPIM 25 years

The Romanian Association of International Pharmaceutical Manufacturers (ARPIM) – an organisation that supports the common objectives of the 27 leading international pharmaceutical companies producing original medicines in Romania – celebrates its 25th anniversary this year. During all this time, the main objective of the Association has been to increase the access of Romanian patients to medicines, to improve the quality of life of patients and implicitly to increase the life expectancy of Romanians, through collaboration and partnership with all the actors involved in the field.

ARPIM members are constantly investing in research and development in order to provide doctors and patients with original and innovative medicines that save thousands of lives every year.

Diana Zaim este foto jurnalist, câștigătoare a Premiul Publicului la European Youth Event 2020, cel mai mare eveniment pentru tineri organizat de Parlamentul European. Absolventă a secției germană-portugheză în cadrul Universității din București, Diana urmează în prezent programul de master ”Relații Internaționale și Integrare Europeană” în cadrul SNSPA. Pasionată de promovarea valorilor europene, Diana este parte a comunității Model European Union, cea mai amplă simulare la nivel european a procesului decizional din cadrul Uniunii Europene.

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MEP Vasile Blaga: Firm decisions are needed to boost vaccination in Romania. We cannot afford new pressure on the health system

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MEP Vasile Blaga (PNL, EPP) believes that “firm decisions are needed to stimulate vaccination in Romania”, stressing that “we cannot afford a new pressure on the health system like in wave 4”.

“The year 2021 ends primarily under the sign of the pandemic generated by COVID 19. We all know the effects of wave 4 in Romania. Even if at the moment the figures are in reasonable ranges, what is happening in countries with high vaccination rates is a warning signal for the new wave of the pandemic. Authorities in Bucharest need to take firm decisions to increase vaccination rates. There is no time for hesitation. Sceptics should take a closer look at the fact that despite high infection figures, the number of deaths and serious cases is low in countries with high vaccination rates. This is where the effectiveness of vaccines can be seen,” said Blaga.

He said that the Romanian health system can no longer afford an over-supply such as in wave 4, which had a major and totally unfair impact on all sick people in Romania.

“We must activate the community spirit in Romania and realise that the fact that we vaccinate helps our neighbours, including the fact that a potential infection with Covid 19 does not deny access to hospital to a patient with a chronic disease,” the MEP added.

“The decision of each of us on vaccination has knock-on effects”, concluded Vasile Blaga.

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MEP Vasile Blaga: Eliminating gender gaps in the European labour market – a priority for the European Parliament

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Closing the gender gap in the European labour market was at the top of last week’s plenary agenda, said MEP Vasile Blaga (PNL, EPP) on Monday.

The European Parliament’s last plenary session this year put gender inequality in the European labour market on the agenda. Statistics show that at EU level there is still a pay gap of more than 14 percentage points (14.1%) between men and women and a wider pension gap of almost 30 percentage points, both to the disadvantage of women. Moreover, the report voted on at the last plenary session of the European Parliament also notes that women face a precarious situation in the labour market.

“Together with the EPP Group in the European Parliament, I voted in favour of the report on gender equality to draw attention once again to the fact that Member States must come up with concrete proposals to minimise gender inequalities and to strongly support women’s rights in the European Union”, said the EPP MEP for CaleaEuropeană.ro.

The report adopted in the European Parliament also focuses on eradicating violence against women, a phenomenon which has increased significantly during the pandemic.

“Abuse against women must be vigorously prosecuted and the perpetrators must be investigated and punished without hesitation. Moreover, monitoring and protection programmes for victims of domestic violence need to be improved in order to minimise this phenomenon”, added Vasile Blaga.

In a non-legislative report adopted last Wednesday by 500 votes to 105 with 87 abstentions, MEPs reiterated that equal pay and equal treatment are an essential prerequisite for women to enjoy equal rights, economic independence and professional fulfilment.

They call on Member States to take practical measures to ensure that women have equal access to the labour market and jobs and that they enjoy equal pay and equal rights as workers. For example, to achieve this, sanctions should be imposed on companies that do not comply with labour law. In this respect, MEPs welcome the Commission’s proposal for mandatory pay transparency measures. However, they stress that pay transparency alone will not be enough to address deep-rooted gender inequalities.

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A government project to digitise healthcare is needed. More calls from Romanian experts at national and European level

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The COVID-19 pandemic has highlighted the need for a health system that can cope with paradigm shifts in remote healthcare, and telemedicine has been a great help to patients as well as doctors over the past two years. Thus, the digitalisation of the health system and health services is a topic of interest at European and national level. However, there is an uneven development of digitisation and e-Health solutions in EU countries in Central and Eastern Europe, according to a report by PricewaterhouseCoopers, for the European Federation of Pharmaceutical Industries and Associations (EFPIA).

National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by www.CaleaEuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the European opportunities for digitisation of the healthcare system in Romania, but also on the steps that our country needs to go through in the digital transition so that Romanian patients can benefit in the coming years from easy access to healthcare and telemedicine.

The main lessons learned by the European Union since the beginning of the pandemic and until now were discussed, as well as the need to accelerate the digital transition in the European Union’s health systems, but especially the importance for the Romanian authorities, regardless of political colour, to establish a unitary strategy for the digitisation of health, a strategy that coordinates the institutions in the field and is connected to European directives.

The digitisation of the Romanian health system must allow transparent access to reliable data which must be published in formats suitable for secondary use, for epidemiological or health policy analysis.

Topics of interest for Romania in the field of digitisation of health can be (non-exhaustive list): European Cancer Knowledge Database; European Cancer Imaging Initiative; Cancer Management Inequalities Registry in Member States; Connecting e-prescribing and electronic patient record systems between Member States; Connecting and exchanging information between reference centres for rare diseases; Participation in transnational registries in the field of chronic diseases; National/transnational remote medical consultations and second opinion in imaging or pathology; Evaluation of health apps for reimbursement, etc.

Develop a government project covering the key issues for digitisation in health, needed

Prof. Dr. Adrian Streinu-Cercel, President of the Health Committee of the Romanian Senate, calls for a government project covering the key aspects of digitisation in health: “To be an integrated system it has to start from one head, i.e. the Romanian Government. If we don’t decide what we want this digitisation to look like, it will be everyone with their own database, everyone with their own application.”

  • We have the opportunity to do a very good job from the beginning and for that we all have to sit around the same table, regardless of political colours, and discuss how we want this national digitisation programme to look like and how to integrate with other countries, if we want that.

Romania needs to establish a National Contact Point to align our country with European directives

Ștefan Busnatu, advisor for digitisation to the Minister of Health, set up a digitisation strategy for the health system a year ago, which unfortunately has not been integrated into the NRDP.

  • We need to establish a National Contact Point, which will deal with the whole digitisation component in order to be aligned with the Brussels directives and all the European reforms. The National Contact Point is a three million euro project, which theoretically has to be taken on by someone. At the moment the CNAS have sent the assumption from a coordination point of view. It is important to decide where it would be most coherent to create the National Contact Point in Romania for digitisation and digital transformation.

The time has come for telemedicine to offer patients a better quality of life, while giving doctors new tools

Adela Cojan, President of the National Health Insurance House, reviewed the latest national milestones for the digital transformation of Romania’s healthcare system. A Memorandum has been signed at governmental level for tripartite participation to access European funds for the development of the project “IT systems for connecting to the electronic health record the providers of paraclinical services, specialist outpatient, rehabilitation, home care, providers of clinical services, palliative, medical devices or emergency consultations at home”, being basically an extension of the electronic health record, which was initially designed only on family medicine and hospitals.

  • The societal and economic benefits of the widespread use of telemedicine are practically enormous. At the moment we are far from being fully in the middle of their use, but I believe the time has come for telemedicine to offer patients a better quality of life, while giving doctors new tools. It is a challenge, there have been reservations, but now in the areas where we have introduced remote consultations they have been widely accepted, which is why we have also extended them in the regulations for next year.

Lack of interoperability of databases in the healthcare system, one of the critical issues

Adrian Hatos, Chairman of the Committee for Science, Innovation and Technology in the Romanian Senate, says that one of the critical problems facing the entire public system in Romania, not only the medical system, but also the administration and education, is the interoperability of databases or the interoperability of data in general in the medical system, which makes it impossible to access and use data: “We have the possibility of datafication, big data techniques and remote communication in education or medicine. The problem in Romania is primarily institutional and human rather than technical.”

  • So far there have been public and European financial resources for digitisation. We need to look at the problem of working with so many database systems that cannot communicate with each other. We have the opportunity of RRF funding, but also the implementation of a governmental Cloud to force the creation or implementation of a data infrastructure that is unitary, standardised at national level, so that we can communicate in the various structures and take advantage of the opportunities that telemedicine offers.
  • The digital transition must also include changing the attitude of doctors and patients towards technology.
  • The Committee on Science, Innovation and Technology of the Romanian Senate can initiate legislation and support legislation in this area. It can initiate debates in the Senate on digitisation in health.

Patient registers, the most important thing today when it comes to digitising health

Felicia Ciulu Costinescu, Director, Medical Technologies Evaluation Directorate, National Agency for Medicines and Medical Devices of Romania (ANMDMR), says that digitisation of healthcare has become a necessity for facilitating the patient pathway in the healthcare system and has become more important in the context of the pandemic.

  • ANMDMR experts are active and present in Brussels working groups of the European Medicines Agency (EMA) or the European Commission, including in task forces dedicated to digital transformation: “This concern comes from the need to provide EU patients with innovative solutions and emerging technologies. All this can only be achieved by transforming and optimising regulatory processes, improving centres of expertise, providing digital solutions and building an e-learning ecosystem. All of this requires investment over time, but the process has been started and will bring the benefits it was designed to deliver.
  • The digitisation paradigm is a complex one. Patient registries are the most important thing at the moment when we talk about digitising health. The need for these registries is even greater as very high-cost personalised therapies are knocking at the door. These registries will be useful when we want to have access to some data. Interconnecting them with both national and existing European health platforms. The main aim is to develop a common dataset to support the reimbursement decision as well as to support technicians to have easy access to medical data.
  • Digital technologies, intelligent data collection and integration are the present and the future for patient access to personalised, effective and safe treatments.

The leadership of the Romanian Digitisation Authority (ADR) gave details of the objectives of the RegInterMed project in its message to the expert meeting on 14 December. According to the ADR, in October the Ministry of Health put the specifications of the RegInterMed project out to public consultation.

  • The project will implement 100 disease registers for 18 specialities. These will be established separately during the implementation period. In addition, 4 specific registers will be implemented for the INSP (Register “reporting biocidal substances”, Drinking water quality register (RECAP), National operational computerised register of occupational diseases, Register on the management of waste resulting from medical activity).
  • It will have a working meeting on Wednesday 15 December with the new management delegated by the Ministry of Health for this project.

The European Commission is exploring the possibility of European patient registers, but the condition is that national registers exist in all EU countries

Cristian Bușoi MEP, Chair of the Industry and Research Committee of the European Parliament’s ITRE Committee, as the European Parliament’s rapporteur for the EU health programme, EU4Health, insisted that one of the priorities of this programme is digitisation in health at European level and the creation of the EU Health Data Space, which is an initiative of the European Commission that he supports.

  • We also advocated that money from this programme should fund interoperability between different e-health systems at national level, such as electronic patient registers to be interconnected and prescription, which is an e-health solution found in most European countries and this needs to be interconnected.
  • The European Commission is looking at the possibility of European patient registries, but the condition is that there should be national registries in all EU countries, at least for cancer and rare diseases where the number of patients is not so large, it would be easier to manage these patients. At European level, digitisation in health is an essential component. EU4Health can only give a general outline, just as the EU Health Data Space will create some rules for governance, for interoperability.
  • Romania needs to prioritise these projects in order to be able to use European funding.

Romania has all the necessary tools to digitise its health system and to offer Romanian patients European and quality conditions in terms of health and telemedicine. It is essential that decision-makers and politicians have forward-looking projects adapted to European requirements so that Romanian patients can benefit from the opportunities of the digital transition.

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